For Patients

Belviq (lorcaserin hydrochloride) is indicated for the treatment of chronic weight management in adults with a body mass index (BMI) of 30 or greater (obese) as an addition to a reduced-calorie diet and exercise. Belviq is also approved for use by adults with a BMI of 27 or greater (overweight) and who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia). It is a serotonin 2C receptor agonist. Side effects from Belviq may include low blood sugar (hypoglycemia), mental problems, slow heartbeat, headache, dizziness, fatigue, nausea, dry mouth, constipation, and painful erections.

Belviq is taken orally. The recommended dosage of Belviq is one 10mg tablets taken twice per day. Belviq should be discontinued if 5% weight loss is not achieved by week 12 of therapy. Belviq may interact with antidepressants, including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), triptans, bupropion, dextromethorphan, or St. John's Wort). Tell your doctor all medications you use. Belviq should not be taken during pregnancy or by women who are planning to become pregnant. Belviq should not be taken while breastfeeding.

Our Belviq Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Clinical Trials Experience

In the BELVIQ placebo-controlled clinical database of
trials of at least one year in duration, of 6888 patients (3451 BELVIQ vs. 3437
placebo; age range 18-66 years, 79.3% women, 66.6% Caucasians, 19.2% Blacks,
11.8% Hispanics, 2.4% other, 7.4% type 2 diabetics), a total of 1969 patients
were exposed to BELVIQ 10 mg twice daily for 1 year and 426 patients were
exposed for 2 years.

In clinical trials of at least one year in duration, 8.6%
of patients treated with BELVIQ prematurely discontinued treatment due to
adverse reactions, compared with 6.7% of placebo-treated patients. The most
common adverse reactions leading to discontinuation more often among BELVIQ
treated patients than placebo were headache (1.3% vs. 0.8%), depression (0.9%
vs. 0.5%) and dizziness (0.7% vs. 0.2%).

Most Common Adverse Reactions

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice.

The most common adverse reactions for non-diabetic
patients (greater than 5% and more commonly than placebo) treated with BELVIQ
compared to placebo were headache, dizziness, fatigue, nausea, dry mouth, and
constipation. The most common adverse reactions for diabetic patients were
hypoglycemia, headache, back pain, cough, and fatigue. Adverse reactions that
were reported by greater than or equal to 2% of patients and were more
frequently reported by patients taking BELVIQ compared to placebo are
summarized in Table 2 (non-diabetic subjects) and Table 3 (subjects with type 2
diabetes mellitus).

Table 2: Adverse Reactions Reported by Greater Than or
Equal to 2% of BELVIQ Patients and More Commonly than with Placebo in Patients
without Diabetes Mellitus

Adverse Reaction

Number of patients (%)

BELVIQ 10 mg BID
N=3195

Placebo
N=3185

Gastrointestinal Disorders

Nausea

264 (8.3)

170 (5.3)

Diarrhea

207 (6.5)

179 (5.6)

Constipation

186 (5.8)

125 (3.9)

Dry mouth

169 (5.3)

74 (2.3)

Vomiting

122 (3.8)

83 (2.6)

General Disorders And Administration Site Conditions

Fatigue

229 (7.2)

114 (3.6)

Infections And Infestations

Upper respiratory tract infection

439 (13.7)

391 (12.3)

Nasopharyngitis

414 (13.0)

381 (12.0)

Urinary tract infection

207 (6.5)

171 (5.4)

Musculoskeletal And Connective Tissue Disorders

Back pain

201 (6.3)

178 (5.6)

Musculoskeletal pain

65 (2.0)

43 (1.4)

Nervous System Disorders

Headache

537 (16.8)

321 (10.1)

Dizziness

270 (8.5)

122 (3.8)

Respiratory, Thoracic And Mediastinal Disorders

Cough

136 (4.3)

109 (3.4)

Oropharyngeal pain

111 (3.5)

80 (2.5)

Sinus congestion

93 (2.9)

78 (2.4)

Skin And Subcutaneous Tissue Disorders

Rash

67 (2.1)

58 (1.8)

Table 3: Adverse Reactions Reported by Greater Than or
Equal to 2% of BELVIQ Patients and More Commonly than with Placebo in Patients
with Type 2 Diabetes Mellitus

Adverse Reaction

Number of patients (%)

BELVIQ 10 mg BID
N=256

Placebo
N=252

Gastrointestinal Disorders

Nausea

24 (9.4)

20 (7.9)

Toothache

7 (2.7)

0

General Disorders And Administration Site Conditions

Fatigue

19 (7.4)

10 (4.0)

Peripheral edema

12 (4.7)

6 (2.4)

Immune System Disorders

Seasonal allergy

8 (3.1)

2 (0.8)

Infections And Infestations

Nasopharyngitis

29 (11.3)

25 (9.9)

Urinary tract infection

23 (9.0)

15 (6.0)

Gastroenteritis

8 (3.1)

5 (2.0)

Metabolism And Nutrition Disorders

Hypoglycemia

75 (29.3)

53 (21.0)

Worsening of diabetes mellitus

7 (2.7)

2 (0.8)

Decreased appetite

6 (2.3)

1 (0.4)

Musculoskeletal And Connective Tissue Disorders

Back pain

30 (11.7)

20 (7.9)

Muscle spasms

12 (4.7)

9 (3.6)

Nervous System Disorders

Headache

37 (14.5)

18 (7.1)

Dizziness

18 (7.0)

16 (6.3)

Psychiatric Disorders

Anxiety

9 (3.5)

8 (3.2)

Insomnia

9 (3.5)

6 (2.4)

Stress

7 (2.7)

3 (1.2)

Depression

6 (2.3)

5 (2.0)

Respiratory, Thoracic And Mediastinal Disorders

Cough

21 (8.2)

11 (4.4)

Vascular Disorders

Hypertension

13 (5.1)

8 (3.2)

Other Adverse Reactions

Serotonin-associated Adverse Reactions

SSRIs, SNRIs, bupropion, tricyclic antidepressants, and
MAOIs were excluded from the BELVIQ trials. Triptans and dextromethorphan were
permitted: 2% and 15%, respectively, of patients without diabetes and 1% and
12%, respectively, of patients with type 2 diabetes experienced concomitant use
at some point during the trials. Two patients treated with BELVIQ in the
clinical program experienced a constellation of symptoms and signs consistent
with serotonergic excess, including one patient on concomitant dextromethorphan
who reported an event of serotonin syndrome. Some symptoms of possible
serotonergic etiology that are included in the criteria for serotonin syndrome
were reported by patients treated with BELVIQ and placebo during clinical
trials of at least 1 year in duration. In both groups, chills were the most
frequent of these events (1.0% vs. 0.2%, respectively), followed by tremor
(0.3% vs. 0.2%), confusional state (0.2% vs. less than 0.1%), disorientation
(0.1% vs. 0.1%) and hyperhidrosis (0.1% vs. 0.2%). Because serotonin syndrome
has a very low incidence, an association between BELVIQ and serotonin syndrome
cannot be excluded on the basis of clinical trial results [see WARNINGS AND
PRECAUTIONS].

Hypoglycemia in Patients with Type 2 Diabetes

In a clinical trial of patients with type 2 diabetes
mellitus, hypoglycemia requiring the assistance of another person occurred in 4
(1.6%) of BELVIQ-treated patients and in 1 (0.4%) placebo-treated patient. Of
these 4 BELVIQ-treated patients, all were concomitantly using a sulfonylurea
(with or without metformin). BELVIQ has not been studied in patients taking
insulin. Hypoglycemia defined as blood sugar less than or equal to 65 mg/dL and
with symptoms occurred in 19 (7.4%) BELVIQ-treated patients and 16 (6.3%)
placebo-treated patients.

Cognitive Impairment

In clinical trials of at least 1-year duration, adverse
reactions related to cognitive impairment (e.g., difficulty with
concentration/attention, difficulty with memory, and confusion) occurred in
2.3% of patients taking BELVIQ and 0.7% of patients taking placebo.

Psychiatric Disorders

Psychiatric disorders leading to hospitalization or drug
withdrawal occurred more frequently in patients treated with BELVIQ (2.2%) as
compared to placebo (1.1%) in non-diabetic patients.

Euphoria. In short-term studies with healthy
individuals, the incidence of euphoric mood following supratherapeutic doses of
BELVIQ (40 and 60 mg) was increased as compared to placebo [see Drug Abuse
and Dependence]. In clinical trials of at least 1-year duration in obese
patients, euphoria was observed in 0.17% of patients taking BELVIQ and 0.03%
taking placebo.

Depression and Suicidality. In trials of at least
one year in duration, reports of depression/mood problems occurred in 2.6%
BELVIQ-treated vs. 2.4% placebo-treated and suicidal ideation occurred in 0.6% BELVIQ-treated
vs. 0.4% placebo-treated patients. 1.3% of BELVIQ patients vs. 0.6% of placebo patients
discontinued drug due to depression-, mood-, or suicidal ideation-related
events.

Laboratory Abnormalities

Lymphocyte and Neutrophil Counts. In clinical
trials of at least 1-year duration, lymphocyte counts were below the lower
limit of normal in 12.2% of patients taking BELVIQ and 9.0% taking placebo, and
neutrophil counts were low in 5.6% and 4.3%, respectively.

Hemoglobin. In clinical trials of at least 1-year
duration, 10.4% of patients taking BELVIQ and 9.3% taking placebo had
hemoglobin below the lower limit of normal at some point during the trials.

Prolactin. In clinical trials, elevations of
prolactin greater than the upper limit of normal, two times the upper limit of
normal, and five times the upper limit of normal, occurred in 6.7%, 1.7%, and
0.1% of BELVIQ-treated patients and 4.8%, 0.8%, and 0.0% of placebo-treated
patients, respectively.

Eye disorders

More patients on BELVIQ reported an eye disorder than
patients on placebo in clinical trials of patients without diabetes (4.5% vs.
3.0%) and with type 2 diabetes (6.3% vs. 1.6%). In the population without diabetes,
events of blurred vision, dry eye, and visual impairment occurred in
BELVIQ-treated patients at an incidence greater than that of placebo. In the
population with type 2 diabetes, visual disorders, conjunctival infections,
irritations, and inflammations, ocular sensation disorders, and cataract conditions
occurred in BELVIQ-treated patients at an incidence greater than placebo.

Echocardiographic Safety Assessments

The possible occurrence of regurgitant cardiac valve
disease was prospectively evaluated in 7794 patients in three clinical trials
of at least one year in duration, 3451 of whom took BELVIQ 10 mg twice daily.
The primary echocardiographic safety parameter was the proportion of patients
who developed echocardiographic criteria of mild or greater aortic
insufficiency and/or moderate or greater mitral insufficiency from baseline to
1 year. At 1 year, 2.4% of patients who received BELVIQ and 2.0% of patients
who received placebo developed valvular regurgitation. The relative risk for
valvulopathy with BELVIQ is summarized in Table 4. BELVIQ was not studied in
patients with congestive heart failure or hemodynamically-significant valvular
heart disease [see WARNINGS AND PRECAUTIONS].